Instagram
youtube
Facebook

Team Member - Qc

1-3 years
Not Disclosed
10 Feb. 7, 2025
Job Description
Job Type: Full Time Education: M.Sc. / B. Pharma Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Team Member – QC

Posting Date: February 4, 2025
Req ID: 89135
Division: Quality
Department: Quality
Employment Type: Permanent
Job Location: Rangpo
Shift Hours: [Specify]


Job Purpose

The Team Member – QC will be responsible for preparing, updating, and reviewing specifications, SOPs, policies, and operational documents for material analysis. The role ensures compliance with pharmacopoeial standards, cGMP requirements, and predefined quality parameters.


Key Accountabilities

1. Preparation & Review of QC Documents

  • Prepare and update SOPs, specifications, and general analytical methods.
  • Ensure timely availability of documents for QC/QA teams.
  • Review pharmacopoeial guidelines and update documents accordingly.
  • Verify instrument calibration data as per operating documents.

2. Pharmacopoeial Compliance & Updates

  • Monitor and review new/revised monographs in the latest pharmacopoeia.
  • Ensure timely implementation of updates to avoid non-conformances.
  • Notify stakeholders to initiate necessary document updates.
  • Escalate non-conformances promptly to avoid operational delays.

3. Document Review & Quality Compliance

  • Review assigned documents to ensure adherence to quality requirements.
  • Follow approved procedures & Cipla policies for document compliance.
  • Identify and resolve queries during document review to prevent delays.

4. Document Issuance & Record Maintenance

  • Issue documents to applicable units and maintain issuance records.
  • Ensure bound books are updated and available for record-keeping.

5. Harmonization & Process Simplification

  • Standardize QC documents across all units at the site.
  • Collaborate with cross-functional teams (CFTs) to optimize procedures.
  • Provide suggestions for document simplification and process improvement.

Education & Experience

Qualifications:

  • M.Sc. / B. Pharma

Experience:

  • 1-3 years in the QC department of a pharmaceutical organization.

Key Competencies & Skills

Technical Expertise – Strong domain knowledge of QC processes and cGMP compliance.
Collaboration – Ability to work with cross-functional teams.
Attention to Detail – Ensuring regulatory and procedural compliance.
Problem-Solving – Identifying and addressing document-related challenges.
Process Optimization – Innovating to simplify and standardize workflows.